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lightrock

07/31/19 9:46 PM

#24009 RE: tarius729 #24008

@tarius

I can only say "probably yes"

Why...

The scenario is this, roughly speaking...

Imagine 200 of the SOC "control" group have expired.
At most, 100 of the MK "test" group can possibly expire at most before 298.

AFTER 8 years, and with everyone ~794 at or beyond 3 years in to the study, if 298 has not happened yet, then THERE WILL BE A 3 YEAR MARKER IN THE LIFE TABLE ANALYSIS - AND - A MASSIVE DIFFERENTIAL that must be accounted for.

It would not be possible for the test and control groups to be "even" and it would not be possible for 200 events to suddenly appear in the test group to wipe out the differential measured at three years in the life table analysis.

In such a case at this, it would be reasonable to conclude the study "We've seen enough, let's go..."

OR "You've done enough this is great, keep following the remainder of the study, however you should go ahead and make your new drug application now."

That sort of thing.

Of course, they could also be very strict, "The experiment was put forth in these terms and must be concluded in these terms." - always a possibility.